High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia (NCT07171593) | Clinical Trial Compass
By InvitationNot Applicable
High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
China44 participantsStarted 2024-03-04
Plain-language summary
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
. Aged 18-50 years;
. Complicated with sarcopenia;
. Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
. Signed informed consent and able to comply with the study procedures;
. Colonic or ileocolonic type CD (SES-CD ≥6; if only terminal ileum is involved, SES-CD ≥4).
Exclusion criteria
. Short bowel syndrome;
. High-output jejunal fistula;
. Severe stress or shock status;
. Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
. Severe hepatic, renal, or cardiac diseases, or malignant tumors;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
muscle strength improvement
Timeframe: Week 4; Week 8
Trial details
NCT IDNCT07171593
SponsorSixth Affiliated Hospital, Sun Yat-sen University